MannKind receives complete response letter for Afrezza

VALENCIA, Calif. — It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

The Food and Drug Administration on Thursday issued a complete response letter to the drug maker regarding Afrezza (insulin human [rDNA origin]) inhalation powder. The regulatory agency requested that the company conduct two clinical trials, one in patients with Type 1 diabetes and one in patients with Type 2 diabetes, with its next-generation inhaler, to assure it works as effectively as MedTone, its predecessor.

"While we are disappointed with the complete response letter, we are encouraged that the FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in our extensive clinical program," said MannKind’s chairman and CEO Alfred Mann. "We remain committed to working with the FDA to make Afrezza available to people with diabetes."

Report: Genzyme CEO calls acquisition by Sanofi-Aventis a long process

BOSTON — Finalizing an acquisition of biotech company Genzyme by French drug maker Sanofi-Aventis “will take some time,” media reports quoted Genzyme’s chief executive as saying.

The Boston Globe quoted Genzyme CEO Henri Termeer as saying it would be a long process to understand the company’s full value, in particular because of an investigational multiple sclerosis drug, Campath (alemtuzumab), which could achieve blockbuster sales and thus raise the company’s value and acquisition price if it wins approval.

Sanofi voiced its intent to buy Genzyme last July for $18.5 billion, or about $69 per share. The Wall Street Journal and Bloomberg reported earlier this month that contingent value rights could raise the price to as much as $80 per share.

In other news, Genzyme announced it would build a $335 million plant in Geel, Belgium, for manufacturing Myozyme and Lumizyme (alglucosidase alfa), used to treat Pompe disease. The company expects to receive approval to market drugs manufactured in the plant in 2014.

Repeal of health reform could end coverage for millions of Americans, White House warns

WASHINGTON — The drive by Republicans to overturn the landmark health-reform legislation enacted last year threatens the health of as many as 129 million Americans with pre-existing conditions, the Obama administration’s top health official warned Tuesday.

In a starkly worded retort to the GOP’s campaign to overturn the Affordable Care Act, Health and Human Services secretary Kathleen Sebelius said repealing the law would put health coverage at risk for a huge segment of the U.S. population. Without the protections afforded by the health-reform law, she warned, as many as 1-in-2 nonelderly Americans could be denied coverage or charged more due to a pre-existing condition when the law takes full effect in 2014.

“The Affordable Care Act is stopping insurance companies from discriminating against Americans with pre-existing conditions and is giving us all more freedom and control over our healthcare decisions,” said Sebelius. “The new law is already helping to free Americans from the fear that an insurer will drop, limit or cap their coverage when they need it most. And Americans living with pre-existing conditions are being freed from discrimination in order to get the health coverage they need.”

The HHS secretary backed her assertion with a new analysis from the federal health agency. That study, she said, shows that “without the Affordable Care Act, up to 129 million nonelderly Americans who have some type of pre-existing health condition, [such as] heart disease, high blood pressure, arthritis or cancer, would be at risk of losing health insurance when they need it most, or be denied coverage altogether.”

Up to 1-in-5 Americans under the age of 65 years with a pre-existing condition — 25 million individuals — are uninsured, according to HHS. “Prior to the Affordable Care Act, in the vast majority of states, insurance companies in the individual market could deny coverage, charge higher premiums and/or limit benefits based on pre-existing conditions,” the agency said. “Surveys have found that 36% of Americans who tried to purchase health insurance directly from an insurance company in the individual insurance market encountered challenges purchasing health insurance for these reasons.”

Health reform already has addressed some coverage gaps, said the agency.

“Insurers can no longer limit lifetime coverage to a fixed dollar amount or take away coverage because of a mistake on an application,” HHS reported Tuesday. “Young adults have the option of staying on their parents’ coverage up to the age of 26 if they lack access to job-based insurance of their own, and insurers cannot deny coverage to children because of a pre-existing condition.”

In addition, according to an HHS representative, “Many uninsured Americans with pre-existing conditions have already enrolled in the temporary high-risk pool program called the pre-existing condition insurance plan [PCIP], which provides private insurance to those locked out of the insurance market because of a pre-existing condition.” The agency describes the PCIP program as “a bridge until 2014, when insurance companies can no longer deny or limit coverage or charge higher premiums because of a pre-existing condition.”

Release of the new report comes as the White House wages an increasingly urgent campaign to head off a Republican effort to repeal the Affordable Care Act. The House voted on the repeal Wednesday, but the GOP effort to set aside the legislation is widely expected to stall in the Senate, which is still controlled by a Democratic majority. Senate GOP leaders are looking to the elections of 2012 in hopes that control will pass to Republicans, potentially clearing the way for a repeal vote in the Senate.

Click here to read the HHS report. More information about the new protections created by the Affordable Care Act and the pre-existing condition insurance plan can be found at HealthCare.gov.

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